Good manufacturing practices and governmental regulations are at the core of any pharmaceutical, biotechnology and bio-medical manufacturing process or procedure. Such manufacturing processes and procedures as well as associated equipment must undergo mandated, often lengthy and costly validation procedures. Similar issues exist for sensors when needed in such systems, such as pH sensors, electrical conductivity sensors and oxygen sensors.
For example, the equipment used for the separation and purification of biomedical products must meet stringent cleanliness requirements. The cleaning validation of new or re-commissioned purification equipment (including sensor equipment, bioreactors, and equipment for preparative chromatography or tangential flow filtration—“TFF”) may require as many as 50 test-swabs of exposed surfaces and subsequent biological assays of such test-swabs. For a single piece of purification equipment, for example, the associated and reoccurring cost of a single cleaning validation may readily exceed multiple thousands of dollars.
Sterilization is accomplished by exposing to gamma irradiation, or to an ethylene oxide atmosphere. Pre-sterilized, aseptically packaged tube/bag manifolds are commercially available (currently from TC Tech; HyClone; St Gobain Performance Plastics, for example) and are used for the manual transfer of solutions. Typically, manual solution transfer procedures require a technician to operate a peristaltic pump and to manually open and close tube clamps for diverting the solution from the reservoir to the storage bags. Although this procedure reduces the cleaning efforts and cleaning validation expense, operator interaction and time still are required, and these approaches are dependent upon operator expertise for consistent accuracy and precision.
It has been found that, by proceeding in accordance with the present embodiments, significant cost savings and better performance can be realized in a system which incorporates automated, aseptic manifolds and sensors within the field of technology that embraces pre-sterilized, single-use containers, including plastic tubing, containers that can have at least one collapsible portion, bags, bioreactor bags, and flow-through analysis tubes, containers and/or bags, and the components and sensors which contact the biological or chemical fluid can be each pre-sterilized, pre-validated and/or disposable after use.